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Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007: Difference between revisions

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| [[Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV]] || G || IV || EN || IV. RECOMMENDATIONS [...] C. Source Documentation and Retention When original observations are entered directly into a computerized system, the electronic record is the source document. Under 21 CFR ...
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Latest revision as of 14:15, 16 July 2026


Document information
Reference USA FDA Guidance for Industry -

Computerized Systems Used in Clinical Investigations May-2007

Validity area USA
Scope(s) G
Document name FDA Guidance for Industry -

Computerized Systems Used in Clinical Investigations

Version / Revision May-2007
Status Current
Document type Official recommendation
Language(s) EN
Description Guidance for Industry Computerized Systems Used in Clinical Investigations
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IVGIVENIV. RECOMMENDATIONS

[...] C. Source Documentation and Retention

When original observations are entered directly into a computerized system, the electr…
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